Title and
abstract |
1 |
(a) Indicate the
study’s design with a commonly used term in the title or
the abstract (p. 1) |
(b) Provide in the
abstract an informative and balanced summary of what was done
and what was found (pp. 4–5) |
Introduction |
Background/rationale |
2 |
Explain the scientific background and
rationale for the investigation being reported (p. 6) |
Objectives |
3 |
State specific objectives, including
any prespecified hypotheses (P-7) |
Methods |
Study design |
4 |
Present key elements of study design
early in the paper (pp. 7–8) |
Setting |
5 |
Describe the setting, locations, and
relevant dates, including periods of recruitment, exposure,
follow-up, and data collection (p. 7–8) |
Participants |
6 |
(a) Give the
eligibility criteria, and the sources and methods of selection
of participants. Describe methods of follow-up, (pp.
7–8) |
(b) For matched
studies, give matching criteria and number of exposed and
unexposed (n/a) |
Variables |
7 |
Clearly define all outcomes,
exposures, predictors, potential confounders, and effect
modifiers. Give diagnostic criteria, if applicable (pp.
8–10) |
Data sources/measurement |
8 |
For each variable of interest, give
sources of data and details of methods of assessment
(measurement). Describe comparability of assessment methods if
there is more than one group, (pp. 8–11) |
Bias |
9 |
Describe any efforts to address
potential sources of bias (pp. 10–11) |
Study size |
10 |
Explain how the study size was arrived
at (pp. 8–10) |
Quantitative variables |
11 |
Explain how quantitative variables
were handled in the analyses. If applicable, describe which
groupings were chosen and why. (p.10–11) |
Statistical methods |
12 |
(a) Describe all statistical methods,
including those used to control for confounding (pp.
10–11) |
(b) Describe any methods used to
examine subgroups and interactions (pp. 10–11) |
(c) Explain how missing data were
addressed (p.11) |
(d) If applicable, explain how loss to
follow-up was addressed (n/a) |
(e) Describe any sensitivity analyses
(n/a) |
Results |
Participants |
13 |
(a) Report numbers of individuals at
each stage of study—eg numbers potentially eligible,
examined for eligibility, confirmed eligible, included in the
study, completing follow-up, and analyzed (p. 11) |
(b) Give reasons for non-participation
at each stage (n/a) |
(c) Consider use of a flow diagram
(Figure 1) |
Descriptive data |
14 |
(a) Give characteristics of study
participants (eg demographic, clinical, social) and information
on exposures and potential confounders (p. 11) |
(b) Indicate number of participants
with missing data for each variable of interest (p. 11) |
(c) Summarize follow-up time (eg,
average and total amount) (n/a) |
Outcome data |
15 |
Report numbers of outcome events or
summary measures over time (pp. 11–13) |
Main results |
16 |
(a) Give unadjusted estimates and, if
applicable, confounder-adjusted estimates and their precision
(eg, 95% confidence interval). Make clear which confounders were
adjusted for and why they were included (Appendix Table 2) |
(b) Report category boundaries when
continuous variables were categorized (pp. Table 1) |
(c) If relevant, consider translating
estimates of relative risk into absolute risk for a meaningful
time period (n/a) |
Other analyses |
17 |
Report other analyses done—eg
analyses of subgroups and interactions, and sensitivity analyses
(pp. 11–13) |
Discussion |
Key results |
18 |
Summarize key results with reference
to study objectives (pp. 14–15) |
Limitations |
19 |
Discuss limitations of the study,
taking into account sources of potential bias or imprecision.
Discuss both direction and magnitude of any potential bias (pp.
17–18) |
Interpretation |
20 |
Give a cautious overall interpretation
of results considering objectives, limitations, multiplicity of
analyses, results from similar studies, and other relevant
evidence (p. 17–18) |
Generalizability |
21 |
Discuss the generalizability (external
validity) of the study results (p. 17–18) |
Other
information |
Funding |
22 |
Give the source of funding and the
role of the funders for the present study and, if applicable,
for the original study on which the present article is based
(pp. 11,19) |